The Recall Desk
ModerateFDA (Drugs)·D-0313-2025·Announced 2025-04-16

Sofosbuvir and Velpatasvir Tablets Recalled for Defective Blister Pack Sealing

Asegua Therapeutics is recalling 18,541 cartons of Sofosbuvir and Velpatasvir tablets nationwide due to defective blister packs that are not properly sealed, resulting in loose tablets in cartons. No illnesses or injuries have been reported.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is FDA Class II with no reported illnesses or injuries. The hazard—improperly sealed blister packs causing loose tablets—is a packaging defect rather than a product defect, consistent with voluntary precautionary recalls.

Plain-English summary

Asegua Therapeutics LLC is recalling 18,541 cartons of Sofosbuvir and Velpatasvir combination tablets (400mg/100mg) due to defective packaging. Blister packs in the affected cartons are not properly sealed, allowing tablets to become loose.

The affected product is sold under the brand name Sofosbuvir and Velpatasvir, manufactured for Asegua Therapeutics LLC, an affiliate of Gilead Sciences. The affected lot is 24ASV002UA with an expiration date of 6/30/2028. The product NDC is 72626-2701-1. The recall covers nationwide distribution in the United States.

Sofosbuvir and Velpatasvir is an oral antiviral combination used to treat chronic hepatitis C. The unsealed blister packs could allow tablets to be exposed to environmental conditions during storage and transportation. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
SOFOSBUVIR AND VELPATASVIR (VELPATASVIR AND SOFOSBUVIR)
Brand
SOFOSBUVIR AND VELPATASVIR
Manufacturer
ASEGUA THERAPEUTICS LLC
Hazard
  • defective-packaging
  • loose-tablets

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot# 24ASV002UA
  • Exp Date: 6/30/2028

Distribution

Distributed nationwide across the United States.